BEUDAMED
    FDA Recall Terminated

    Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551

    Recall: Z-0556-06 · Initiated February 9, 2006

    Recall

    Recall Number
    Z-0556-06
    Event Number
    34574
    Firm
    Lumenis Inc.
    FEI Number
    2914019
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2006
    Posted
    February 23, 2006
    Terminated
    August 28, 2006
    Address
    2400 Condensa St, Santa Clara, CA, 95051-0901

    Description

    Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551

    Reason

    During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.

    Action

    On 2/9/06, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. In May 2005, Lumenis mailed a 'Dear Doctor' letter to LightSheer Diode Laser System customers describing more detailed cleaning procedures to be used on the sapphire tips due to skin burns patients' were experiencing from debris build-up on the tip.

    Distribution

    The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.

    Quantity

    3,426 units